The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
Why You Should Attend:
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. The course will cover topics relating to full product life-cycle management, as well as, address the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.
o Generic Products & Bioequivalence Testing
o Biologics & Biosimilars
o Orphan Drug Special Processes
o Compassionate Use / Special Access
· Medical Device Registrations & Product Licenses
· Device Classifications
· Amendments / Variations
· Device Renewal Applications
· Drug / Device Master File (DMF): Use in Latin America
· Processing Variations on Licensed Products.
· Labeling & Packaging Leaflet Requirements
· Drug / Device Vigilance & Post-Marketing Responsibilities
· Import / Export Procedures
· Patents / Copyrights / Trademarks
· Advertising & Promotion of Products
· How and When to Influence the Regulatory Process.
· The Regulatory Negotiation Process.
· How to Use Regulations / Regulatory Contacts to Your Advantage.
· Recent Country Legislation: New Regulations
· Resources / Helpful Websites.
Who Will Benefit:
Duration: 3 Hours
Group of 3 to 5
Group of 6 to 10 + DVD-USB
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Robert J. Russell, (Bob) is the President of RJR Consulting, Inc. RJR Consulting Inc. specializes in understanding global regulatory issues for the pharmaceutical industry. Bob has more than 25 years of experience working with FDA and the Commission on technical issues as they relate to policy development, regulation, clinical trial and the medical device development process. Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 firms. These companies were major raw material suppliers to the pharmaceutical and medical device industry and one a joint-venture parent of a major pharmaceutical division.